Nurix Therapeutics
Director, Regulatory Affairs
Brisbane, California, United States · Director
Sponsorship not specified$220k-$254kDetected 3 days ago
Project ManagementExcelPatient CareFDA RegulatoryCommunicationCollaborationCritical ThinkingRegulatory Affairs
About the role
- Nurix aims to establish degrader-based treatments at the forefront of patient care, writing medicine's next chapter with a new script to outmatch disease.
- Nurix Therapeutics, Inc. is seeking a Director, Regulatory Affairs (Strategy, I&I) to join the Regulatory team.
- This position works cross-functionally with regulatory affairs and clinical development organizations to facilitate the completion of regulatory filing documentation according to company timelines.
Responsibilities
- Develop and implement competitive and effective global clinical & nonclinical regulatory strategies for various immunology and inflammation indications and identify potential risks and mitigation strategies associated with proposed strategies
- Work in close collaboration with the SVP, Head of Regulatory Affairs and the development team leader and other cross-functional colleagues, including CROs to deliver sound, efficient development strategies and operational plans
- Lead and manage the development and preparation of high-quality global submissions (including IND, CTAs, NDAs, and MAAs) for early and late-stage programs in collaboration with the regulatory and project teams to support and accelerate clinical development and regulatory approval, as applicable
- Develops and executes, or oversees global regulatory strategy for long-term planning, including the potential to accommodate expedited development needs
- Plays an essential part in defining requirements for, implementing, and supporting future systems and tools to be employed by Nurix in the areas of document management, submission content planning, and regulatory information management
- Tracks the status of major deliverables for regulatory submissions (e.g., study reports, summary documents, labeling) along with their dependencies
- Develops and maintains submission plan templates to ensure Nurix regulatory submissions are consistently planned and executed across programs
- Manages consultants and contractors as needed
- Proven ability to manage multiple projects, identify and resolve regulatory issues
Requirements
- Must have minimum of 12 years in Regulatory affairs strategy with significant experience in the immunology and inflammation therapeutic area
- Strong demonstration of knowledge of drug development, FDA, EMA and ICH guidelines and regulations
- Proven track record of supporting Regulatory affairs in the planning and execution of major filings and ongoing maintenance of clinical trial and marketing applications
- Experience applying project management techniques and tools (e.g., MS Project, Smartsheet, Excel trackers) to the planning and execution of regulatory submissions
- Strong interpersonal skills and the ability to effectively work with others
Nice to have
- Bachelor's degree in life-sciences or related scientific discipline
- advanced degree preferred Manager:
- advanced degree preferred
Compensation
- Salary Range: 220K – 254K plus bonus and equity.
Benefits
- Experience providing hands-on support for planning clinical trial and marketing applications to health authorities including but not limited to FDA, EMA
- Lead communication with global Health Authorities (HA), such as FDA and EMA, including, planning and preparing for formal meetings with regulatory agencies and interpreting HA feedback from these interactions.
Company info
- Ability to work independently as well as part of a team environment
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